Formula maker Abbott faces DOJ criminal investigation following infant deaths

Formula maker Abbott faces DOJ criminal investigation following infant deaths

The Abbott manufacturing plant in Sturgis, Michigan on May 13, 2022.
Enlarge / The Abbott manufacturing plant in Sturgis, Michigan on May 13, 2022.

The Justice Department’s consumer protection arm has opened a criminal investigation into the conduct of Abbott Laboratories, one of the nation’s largest formula makers, at the center of a nationwide shortage and contamination scandal.

The existence of the investigation was first reported by The Wall Street Journal. Although the Justice Department would not comment on the matter, an Abbott spokesperson said the department has informed them of the investigation and that the company is “fully cooperating.”

Federal regulators last year found numerous violations and “grossly unsanitary” conditions at Abbott’s plant in Sturgis, Michigan, the nation’s largest formula maker. Regulators previously received reports that at least four babies who drank formula made at the facility became ill with dangerous infections from the bacteria. cronobacter sakazakii, which had also been detected in the plant. Two of the babies died.

The Food and Drug Administration also received a complaint from whistleblowers alleging security violations, record falsifications and cover-ups at the facility. But it took several months for that complaint to reach top FDA officials, during which time one baby died and others became ill. The FDA’s clumsy handling of the complaint drew backlash from lawmakers and prompted an external review of the agency.

Meanwhile, Abbott denied that his formula was to blame for infant illnesses and deaths. The company argued that the strains of C. sakazakii found at its Sturgis facility did not genetically match a strain found in an open formula container from one of the sick infant’s homes, which matched the strain infecting that infant, or a strain infecting another of the infants. (There is no genetic data on the strains that infect the other two babies.) FDA food safety experts rejected Abbot’s argument, noting that multiple strains of C. sakazakii were found at the plant and that the facility’s sampling could easily have missed other strains. They also noted that the absence of bacteria in tests of the company’s final product is inconclusive; Testing small batch quantities of formula that are hundreds of thousands of pounds in total will almost always miss low-level contamination.

“Not wanting or not being able to”

The FDA investigation led to the closure of the Sturgis facility last February, exacerbating formula shortages across the country. Parents were left facing empty store shelves as they desperately searched for food for their children, some of which required special formulas. Federal officials rushed to increase supply, waiving regulations and tariffs, and bringing in formula from abroad. Although the shortage has eased somewhat, the supply has not yet recovered. Reckitt Benckiser, the maker of Enfamil, reported in December that he expects the shortage to last until spring.

In order to get the Sturgis plant back up and running safely, Abbott entered into a legal agreement, called a consent decree, with the FDA last May, which laid out the strict steps Abbott would have to take to safely reopen the facility.

In an accompanying complaint, the Justice Department exposed a series of violations and failures found at the Sturgis facility, including that the company’s own tests revealed ongoing contamination of C. sakazakii at the facility and that the FDA had issued prior warnings.

“Continued deficiencies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of foods manufactured for infants, a group of consumers particularly vulnerable to foodborne pathogens,” the department wrote. .

The Wall Street Journal notes that the department has successfully prosecuted other food companies and their executives for bringing contaminated food to market. In 2020, for example, the Blue Bell ice cream company paid $19 million and pleaded guilty to shipping contaminated ice cream linked to a listeria outbreak that killed three. In 2015, former Peanut Corp. of America owner Stewart Parnell was found guilty of numerous charges related to a Salmonella outbreak that killed nine and sickened more than 700. He was sentenced to 28 years in prison.

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